The Diversity Project: Factors Influencing Participation in Clinical Research
The purpose of this study is to investigate the factors influencing participation in clinical research. More specifically, it is to determine if gender and race/ethnicity are major contributors to the disparity seen in participation. Using surveys in various clinics/outpatient facilities within the Lehigh Valley Health Network such as Family Medicine and Emergency Medicine, we hope to achieve a better understanding of patient’s feelings/thoughts about participation in clinical research. The survey focuses on what differences exist between genders and between races and ethnicities with regards to barriers that may prevent and factors that may motivate patients to participate in clinical research. Ultimately, we would like to develop and provide tools and resources to breakdown the barriers that cause less female and minority participation in clinical research and strive for equity and diversity among the clinical research field.
There has been a significant disparity in clinical research regarding female and minority participation. Historically, Caucasian patients are more likely to participate in clinical research as compared to African-American or Latin American patients. Also, males have a higher participation rate in clinical research as compared to females.
Gender disparity has been seen in several studies. One study involved impoverished Mexican-American women and the side effects of oral contraceptives. Pregnancy was a possibility for the women who were given the placebo1. This study resulted in the Department of Health and Human Services to categorize pregnant women as a “vulnerable population” in 1975.
Serious deformities were observed in the children born of women who took Thalidomide during pregnancy. Subsequently, the Food and Drug Administration prohibited women capable of bearing children to participate in Phase I drug trials. Unfortunately, women ended up being excluded from all drug trials. As a result, several drugs had to be withdrawn from the US markets as they were later found to cause greater risks and side effects to women than men. Clearly, it is vital that women be included in early phase clinical trials to accurately determine dosages and prevent negative side effects2.
Racial/ethnic disparity is also a serious problem. Studies show that African-American and Hispanic women participate in clinical research less than Caucasian women and Spanish speaking women participate less than English speaking women3. Undoubtedly, it is crucial to overcome this mistrust to include a diverse group of participants in clinical research.
Although it is known that women and minorities have participated less in clinical research, there have been no specific studies conducted to study this finding that involve large patient populations across different specialties of medicine. Thus, this study is more comprehensive than any other investigation completed in the past. Patient’s attitudes and motivations towards participation in clinical research and the most helpful resources to overcome barriers that create disparities will be investigated.
This study seeks to address local patient populations’ experiences, attitudes and openness regarding participation in clinical research, identify factors that influence women and minorities to participate in clinical research, and assess interest and significance of promotional tools such as DVDs and trial support groups targeted toward patient populations to promote equity in clinical research. More specifically, this report will examine patient perspectives on motivating factors to participate in clinical research in Family Medicine clinics/outpatient facilities within the Lehigh Valley Health network.
An IRB approved survey identifying demographics (i.e. education, occupation, income, race) and attitudes towards motivating factors, barriers, and promotional tools regarding participation in clinical research was developed. Although the survey includes demographic information no identifiers or Protected Health Information was collected. Clinics/outpatient facilities within the Lehigh Valley Health Network were contacted to obtain permission to administer patient surveys in the waiting room. The survey was conducted at Bethlehem Family Medicine, Lehigh Valley Family Health Center at Chew Street, Community Wellness Center, and Lehigh Family Medicine Associate. A short introduction as well as the voluntary nature of the survey was explained to each patient. The survey was administered after gaining consent from the patients. Survey responses were saved in a password-protected database available only to the PI and the research coordinator.
Factors 3, 4, 6, 7, 8, and 9 from the Motivating Factors section of the survey were analyzed, as they were the only unaltered questions throughout the distribution of surveys. Factors were define as follows:
How well the research study is explained to me
My desire to please the doctor
A friend or family member participating in the same study
The doctor conducting the research is the same gender (sex) as me
The doctor conducting the research is the same race/ethnicity as me
The doctor conducting the research speaks the same language as I do
Patients were asked to score each factor based on whether it would motivate them to participate in a clinical research study. The scores went from 0-4 with 0 being defined as No Motivation and 4 being defined as Most Motivation. The results were tallied for each factor and the overall mean score was calculated for each of the six factors. Then four demographics were used to analyze the data: age, race/ethnicity, education level, and income level. Within each demographic the mean score for each of the six factors was calculated and plotted on bar graphs to look for trends in the data.
Figure 1. Mean Scores to F3, F4, F6, F7, F8, and F9 within the Age demographic
Figure 2. Mean Scores to F3, F4, F6, F7, F8, and F9 within the Race/Ethnicity demographic
Figure 3. Mean Scores to F3, F4, F6, F7, F8, and F9 within the Education demographic
Figure 4. Mean Scores to F3, F4, F6, F7, F8, and F9 within the Income demographic
The overall mean scores for the six factors (F3, F4, F6, F7, F8, and F9) were 3.194, 1.207, 1.671, 0.954, 0.619, and 1.732 respectively. This data indicates that the most important motivating factor for patients is how well the research study is explained to them and thus should be the focus of future researchers when recruiting patients for clinical trials. Factors 7 and 8 indicated that all patients cared the least about whether the doctor conducting the research was the same gender or race/ethnicity as them. Across all four of the demographics analyzed factor 3 was again the most important to patients and factors 7 and 8 were the least important.
Some results within the demographics were more noteworthy. Looking further at factor 3 within the age demographic (Figure 1) there is a slight downward trend as age increases indicating that the older the person gets the less they care about how well the research study is explained to them. Examining Figure 2 on race/ethnicity, one can see that Asians placed the most value on a friend or family member participating in the same study. Blacks/African-Americans and Hispanics were the most motivated by their desire to please the doctor. Analyzing Figure 3 on education for factor 3, the greater the education the more the patient cared about how well the research study was explained to them. Additionally, the more educated the patient was the less they cared about pleasing the doctor. Tying income to motivating factors, Figure 4 showed a general upward trend for factor 3 as income increased. In these and other cases, the data showed an apparent increasing or decreasing trend except for one category within a demographic. This indicates that more analysis is needed to see whether this is due to sample size, outliers, or if it is a real finding. Overall, the data from the motivating factors tied to the demographics of the patients indicate the differences in attitudes that may help explain the historical differences in clinical research participation rate.
As with any study, there were limitations. The survey-based method used for this study depended on the response rate of the patients that were approached. Thus, some patients declined to take the survey or accepted to take the survey and did not complete it. Declined surveys and incomplete surveys could be due to lack of motivation or fatigue. The surveys were not always available in Spanish or Chinese, which skewed the data towards English speaking patients. Changes were also made to the survey throughout the summer particularly in the Motivating Factors section, which prevented some of the data from being analyzed. Since this was only one part of a larger study there was a small sample size that included patients from only one specialty, Family Medicine, within one health network, Lehigh Valley. The study would have benefitted from a larger sample size that included a greater number of total surveys and from a variety of specialties from multiple health networks.
Future hopes for the study are to continue to expand the project into different specialties and increase the total number of patient surveys. The results can be used to enhance motivations, overcome barriers, and establish helpful resources for equity in gender and race in clinical research.
- Goldzieher, J.W., Moses, L., Averkin, E., Scheel, C. & Taber, B. (1971). A placebo-controlled double-blind crossover investigation of the side effects attributed to oral contraceptives. Fertility and Sterility, 22(9), 609-623.
- Simon, V. (2005). Wanted: women in clinical trials. Science (New York, N.Y.), 308(5728), 1517.
- Giuliano, A., Mokuaku, N., Hughes, C., Tortolero-Luna, G., Risendal, B., Ho, R., & McCaskill-Stevens, W. (2000). Participation of minorities in cancer research: the influence of structural, cultural and linguistic factors. Annals of Epidemiology, 10(8 Suppl), S22-S34
Published In/Presented At
Winter,A., (2014, July, 25) The Diversity Project: Factors Influencing Participation in Clinical Research. Poster presented at LVHN Research Scholar Program Poster Session, Lehigh Valley Health Network, Allentown, PA.
Research Scholars, Research Scholars - Posters